Hyperpolarized 13C MRI to Predict Response in Pancreatic Cancer

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT06600906
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hyperpolarized 13C-Pyruvate — DRUG
    Given intravenously (IV)
  • Computed tomography (CT) — PROCEDURE
    Undergo CT imaging
  • Magnetic Resonance Imaging (MRI) — PROCEDURE
    Undergo MRI imaging

Study Details

This study evaluates an investigational scan called hyperpolarized carbon-13 pyruvate magnetic resonance imaging (MRI) in assessing treatment response in patients with pancreatic ductal carcinoma (PDA) that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). MRI is a standard scan that helps doctors see tumors, organs, tissue, and bone. Standard contrast agents (e.g., gadolinium) are sometimes used to help make the scan images brighter, or easier to see. Hyperpolarized carbon-13 pyruvate is an experimental contrast agent that is different from standard MRI contrast in that it provides information on how a tumor processes nutrients. Hyperpolarized carbon-13 pyruvate MRI scans may work better than MRI with standard contrast agents in predicting how PDA tumors respond to treatment.

Key Dates

Start date
Oct 1, 2024
Status verified
Nov 2025
Primary completion
Aug 1, 2030
Completion
Sep 1, 2032

Study Design

Enrollment
70 participants (estimated)

Arms

  • Arm: Cohort A (HP 13C pyruvate, MRI)
    Participants with advanced/non-resectable pancreatic ductal adenocarcinoma (PDA) receive HP 13C pyruvate intravenously (IV) and undergo MRI scans prior to receiving standard-of-care (SOC) treatment and again at 4 weeks after starting SOC treatment. Participants may optionally undergo an additional HP 13C pyruvate MRI scan at 8 weeks after starting SOC treatment. Participants who have excellent response and deemed candidates for surgical resection may be switched to Cohort B. Participants also undergo CT and additional MRI scans throughout the study.
  • Arm: Cohort B (HP 13C pyruvate, MRI)
    Participants with localized PDA who are deemed candidates for neoadjuvant therapy (NAT) receive HP 13C pyruvate IV and undergo MRI scans prior to starting NAT and again at 4 weeks after starting NAT. Participants may optionally undergo an additional HP 13C pyruvate MRI scan at 8 weeks after starting NAT. Participants who develop rapidly progressive disease and are deemed non-resectable may be switched to Cohort A. Participants also undergo CT and additional MRI scans throughout the study.

Primary Outcome Measure

Proportion of participants with best objective response (Cohorts A and B) [ Time Frame: Up to 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
Louise Magat
[email protected]
(415) 502-1822
[email protected]
877-827-3222
Zhen Wang, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Francisco, CA

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
University of California, San Francisco· San Francisco, CA

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